A Study of DZD9008 Versus Platinum-Based Doublet Chemotherapy in Local Advanced or Metastatic Non-small Cell Lung Cancer (WU-KONG28)
NCT ID: NCT05668988
Last Updated: 2025-09-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
324 participants
INTERVENTIONAL
2022-12-13
2027-10-31
Brief Summary
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Primary objective of this study is to assess the efficacy of DZD9008 versus platinum-based doublet chemotherapy using by BICR-assessed PFS per RECIST 1.1 as primary endpoint. Approximately 320 participants are estimated to be randomized into the study. Participants enrolled will be randomized to DZD9008 or platinum-based doublet chemotherapy in a 1:1 manner, stratified by baseline brain metastasis (with/without).
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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sunvozertinib
sunvozertinib
orally, 300 mg, once daily until a treatment discontinuation criterion is met.
Platinum-based Chemotherapy
Pemetrexed+carboplatin
Participants randomized into chemotherapy arm can receive up to 6 cycles of pemetrexed + carboplatin (pemetrexed 500 mg/m2 + carboplatin area under the plasma concentration-time curve 5 mg/ml per minute (AUC5), IV infusion, every 3 weeks) as the initial treatment. Participants whose disease has not progressed after 4 cycles of first-line platinum-based doublet chemotherapy may receive pemetrexed maintenance monotherapy until a treatment discontinuation criterion is met.
Interventions
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sunvozertinib
orally, 300 mg, once daily until a treatment discontinuation criterion is met.
Pemetrexed+carboplatin
Participants randomized into chemotherapy arm can receive up to 6 cycles of pemetrexed + carboplatin (pemetrexed 500 mg/m2 + carboplatin area under the plasma concentration-time curve 5 mg/ml per minute (AUC5), IV infusion, every 3 weeks) as the initial treatment. Participants whose disease has not progressed after 4 cycles of first-line platinum-based doublet chemotherapy may receive pemetrexed maintenance monotherapy until a treatment discontinuation criterion is met.
Eligibility Criteria
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Inclusion Criteria
2. Histologically or cytologically confirmed diagnosis of non-squamous NSCLC, locally advanced (Stage IIIB and IIIC according to the 8th edition of the AJCC TNM staging criteria) or metastatic (Stage IV), not suitable for curative therapy.
3. Adequate tumor tissue available, for central laboratory confirmation of EGFR exon 20 insertion mutation
4. At least 1 measurable lesion per RECIST Version 1.1
5. Life expectancy ≥ 12 weeks
6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
7. Adequate organ and hematologic function
Exclusion Criteria
2. Spinal cord compression or leptomeningeal metastasis.
3. Concurrent EGFR mutations: exon 19 deletion, L858R, T790M, G719X, S768I, or L861Q.
4. History of stroke or intracranial hemorrhage within 6 months before randomization.
5. As judged by the investigator, any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses (i.e., hemophilia and Von Willebrand disease).
18 Years
ALL
No
Sponsors
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Dizal Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Caicun Zhou
Role: PRINCIPAL_INVESTIGATOR
Shanghai Pulmonary Hospital, Shanghai, China
Locations
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OPN Healthcare, Inc.
Glendale, California, United States
Kaiser Permanente Medical Center
Vallejo, California, United States
University of Colorado Hospital - Anschutz Cancer Pavilion
Aurora, Colorado, United States
D&H Cancer Research Center
Margate, Florida, United States
Brcr Global
Plantation, Florida, United States
H. Lee Moffitt Cancer Center
Tampa, Florida, United States
NYU Laura & Issac Perlmutter Cancer Center
New York, New York, United States
Columbia University Medical Center
New York, New York, United States
Gabrail Cancer Center Research
Canton, Ohio, United States
The Ohio State University
Columbus, Ohio, United States
Providence Portland Medical Center
Portland, Oregon, United States
USOR - Texas Oncology - Baylor Charles A. Sammons Cancer Center
Dallas, Texas, United States
MD Anderson cancer center
Houston, Texas, United States
USOR - Texas Oncology--Weslaco
Weslaco, Texas, United States
University of Virginia Comprehensive Cancer Center
Charlottesville, Virginia, United States
Centro de Educación Médica e Investigaciones Clínicas, CEMIC
Buenos Aires, , Argentina
Centro Diabaid
Buenos Aires, , Argentina
Centro Medico Austral
Buenos Aires, , Argentina
Consultorios Medicos Dr. Doreski - Fundacion Respirar
Buenos Aires, , Argentina
Fundacion Cenit Para El Estudio De Neurociencias
Buenos Aires, , Argentina
Hospital Italiano de Buenos Aires (HIBA)
Buenos Aires, , Argentina
Instituto Alexander Fleming
Buenos Aires, , Argentina
Instituto Argentino de Diagnositco y Tratamiento S.A
Buenos Aires, , Argentina
Fundación Estudios Clínicos
Rosario, , Argentina
Fundación Ars Médica
San Salvador, , Argentina
Centro de Investigación Clínicas. Clinica Viedma S.A
Viedma, , Argentina
Concord Cancer Centre Medical Oncology Clinical Trials Unit Concord Repatriation General Hospital
Concord, , Australia
Peter MacCallum Cancer Centre
Melbourne, , Australia
Sir Charles Gairdner Hospital, Heart Research Insititute
Nedlands, , Australia
Prince of Wales Hospital
Randwick, , Australia
Ordensklinikum Linz GmbH Elisabethinen
Linz, , Austria
Uniklinikum Salzburg
Salzburg, , Austria
Antwerpen University Hospital (UZA)
Edegem, Antwerp, Belgium
University Hospital Gent- Drug Research Unit Ghent (D.R.U.G.)
Ghent, Flanders, Belgium
Grand Hopital de Charleroi (GHdC) - Hopital Notre Dame
Charleroi, Hainaut, Belgium
Fundacao PIO XII - Hospital do Cancer de Barretos
Barretos, , Brazil
Centro de Pesquisas Clinicas em
Cachoeiro de Itapemirim, , Brazil
Liga Norte Riograndense Contra o Câncer
Natal, , Brazil
Hospital São Lucas da PUCRS
Porto Alegre, , Brazil
Santa Casa de Misericordia- Porto Alegre - Hospital Santa Rita
Porto Alegre, , Brazil
Instituto D'Or de Pesquisa e Ensino - Recife
Recife, , Brazil
Instituto America(COI)
Rio de Janeiro, , Brazil
Instituto D'Or de Pesquisa e Ensino
Rio de Janeiro, , Brazil
Instituto Nacional de Cancer Jose Alencar Gomes da Silva
Rio de Janeiro, , Brazil
Instituto do Cancer do Estado de Sao Paulo - ICES
São Paulo, , Brazil
Regional Cancer Program London Health Sciences Centre
London, , Canada
The Ottawa Hospital Cancer Center
Ottawa, , Canada
Princess Margaret Cancer Center
Toronto, , Canada
Beijing Cancer Hospital
Beijing, , China
Beijing Chest Hospital, Capital Medical University
Beijing, , China
Cancer Hospital of the Chinese Academy of Medical Sciences
Beijing, , China
Peking Union Medical College Hospital
Beijing, , China
Peking University Third Hospital
Beijing, , China
Hunan Cancer Hospital
Changsha, , China
West China Hospital of Sichuan University
Chengdu, , China
Army Medical Center of PLA
Chongqing, , China
Chongqing Cancer Hospital
Chongqing, , China
Fujian Cancer Hospital
Fuzhou, , China
Fujian Medical University Union Hospital
Fuzhou, , China
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, , China
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, , China
The First Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, , China
Zhejiang Cancer Hospital
Hangzhou, , China
Harbin Medical University Cancer Hospital
Harbin, , China
Anhui Provincial Hospital
Hefei, , China
The First Affiliated Hospital of Anhui Medical University
Hefei, , China
The Affiliated Hospital of Inner Mongolia Medical University
Hohhot, , China
Jilin Cancer Hospital
Jilin, , China
Central Hospital Affiliated to Shandong First Medical University
Jinan, , China
Shandong Cancer Hospital & Institution
Jinan, , China
Yunnan Cancer Hospital
Kunming, , China
The Second Affiliated Hospital of Nanchang University
Nanchang, , China
Jiangsu Cancer Hospital
Nanjing, , China
Jiangsu Provincial Hospital
Nanjing, , China
Guangxi Medical University Cancer Hospital
Nanning, , China
Shanghai Chest Hospital
Shanghai, , China
Shanghai Pulmonary Hospital
Shanghai, , China
ZhongShan Hospital Fudan University
Shanghai, , China
The First Hospital of China Medical University
Shenyang, , China
Cancer Hospital Chinese Academy of Medical Sciences, ShenZhen center
Shenzhen, , China
The Fourth Hospital of Hebei Medical University
Shijiazhuang, , China
Shanxi Provincial Cancer Hospital
Taiyuan, , China
Taizhou Hospital of Zhejiang Province
Taizhou, , China
Tianjin Medical University Cancer Institute & Hospital
Tianjin, , China
Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology
Wuhan, , China
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, , China
The First Affiliated Hospital of Xi 'an Jiaotong University
Xi'an, , China
Yantai Yuhuangding Hospital
Yantai, , China
Henan Cancer Hospital
Zhengzhou, , China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, , China
Fakultni Nemocnice Olomouc (FNOL) - Onkologicka Klinika
Olomouc, , Czechia
Vitkovicka Nemocnice a.s. - Plicni oddeleni
Ostrava, , Czechia
Centre Hospitalier Universitaire d'Angers
Angers, , France
Hôpital Louis Pradel
Bron, , France
Centre Hospitalier Intercommunal de Creteil (CHIC)
Créteil, , France
Centre Hospitalier Universitaire de Lille (CHU Lille) - Hopital Albert Calmette - Clinique des Maladies Respiratoires
Hellemmes-Lille, , France
Centre Hospitalier Universitaire Grenoble Alpes (CHU Grenoble Alpes) - Hopital Albert Michallon
La Tronche, , France
APHM-Hôpital NORD
Marseille, , France
Centre de Cancérologie Montpellier
Montpellier, , France
APHP Hôpital Tenon
Paris, , France
Cochin Hospital
Paris, , France
Hopital Saint Joseph
Paris, , France
Hôpital Bichat - Claude Bernard
Paris, , France
CHU Poitiers
Poitiers, , France
Centre Hospitalier Universitaire de Nantes (CHU de Nantes)
Saint-Herblain, , France
Institut de Cancerologie de L'Ouest
Saint-Herblain, , France
Hopital d'Instruction Des Armees Begin
Saint-Mandé, , France
Hopital Foch
Suresnes, , France
Evangelische Lungenklinik Berlin - Klinik fuer Pneumologie
Berlin, , Germany
Asklepios Klinik Gauting GmbH - Klinik fuer Thorakale Onkologie
Gauting, , Germany
Niels-Stensen-Kliniken - Franziskus-Hospital Harderberg
Georgsmarienhütte, , Germany
Universitaetsklinikum Heidelberg (UKHD) - Thoraxklinik-Heidelberg gGmbH
Heidelberg, , Germany
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz - III. Medizinische Klinik und Poliklinik
Mainz, , Germany
Pius-Hospital Oldenburg - Klinik fuer Haematologie und Onkologie
Oldenburg, , Germany
Centro di Riferimento Oncologico (CRO Aviano)
Aviano, , Italy
Azienda Ospedaliero Universitaria di Bologna - Policlinico S. Orsola-Malpighi
Bologna, , Italy
Azienda Ospedaliero - Universitaria "Policlinico-Vittorio Emanuele" Catania
Catania, , Italy
Università degli Studi di Firenze - Azienda Ospedaliero-Universitaria Careggi (AOUC) - SC di Oncologia MedicaI
Florence, , Italy
Azienda USL Toscana Sud Est -Ospedale Misericordia - Grosseto
Grosseto, , Italy
Servizio Sanitario Regionale Emilia-Romagna - Istituto Scientifico Romagnolo per lo Studio e La Cura dei Tumori Srl (IRST)
Meldola, , Italy
Azienda Ospedaliero-Universitaria di Modena (AOU Modena) - Policlinico di Modena
Modena, , Italy
Azienda Ospedaliera San Gerardo - Monza
Monza, , Italy
La Maddalena Casa di Cura di Alta Specialita - Palermo
Palermo, , Italy
Azienda Ospedaliero-Universitaria di Parma
Parma, , Italy
Azienda Unità Sanitaria Locale Romagna
Ravenna, , Italy
Azienda Ospedaliera di Reggio Emilia - Arcispedale S. Maria Nuova (ASMN)
Reggio Emilia, , Italy
IRCCS Istituti Fisioterapici Ospitalieri- Istituto Nazionale tumori Regina Elena
Roma, , Italy
Azienda Ospedaliera Universitaria Senese - Istituto Toscano Tumori (ITT) - Center for Immuno-Oncology (CIO)
Siena, , Italy
Universiteit Maastricht (UM) - Maastricht University Medical Centre (Maastricht UMC+)
Maastricht, , Netherlands
Uniwersyteckie Centrum Kliniczne, Klinika Onkologii i Radioterapii
Gdansk, , Poland
MED-POLONIA Sp. z o.o.
Poznan, , Poland
Wojewódzki Szpital im. św. Ojca Pio
Przemyśl, , Poland
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie Panstwowy
Warsaw, , Poland
Institut Catala d'Oncologia Badalona (ICO Badalona) - Hospital Germans Trias i Pujol
Barcelona, Barcelona, Spain
Complejo Hospitalario Universitario A Coruña
A Coruña, , Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, , Spain
Hospital Universitari Vall d'Hebron
Barcelona, , Spain
Instituto Oncológico Dr Rosell Hospital Quiron Dexeus
Barcelona, , Spain
UOMI Cancer Center - Clinica Tres Torres
Barcelona, , Spain
Institut Catala d'Oncologia de Girona -Hospital Universitari Dr Josep Trueta
Girona, , Spain
Hospital Universitario de Jerez
Jerez de la Frontera, , Spain
Clínica Universidad de Navarra - Madrid
Madrid, , Spain
Hospital HM Sanchinarro
Madrid, , Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
Hospital Universitario Fundación Jiménez Diaz
Madrid, , Spain
Hospital Universitario La Paz
Madrid, , Spain
Hospital Regional Universitario de Málaga
Málaga, , Spain
Hospital Universitario Virgen de Valme
Seville, , Spain
Hospital Universitario Virgen del Rocio
Seville, , Spain
Hospital Universitario Virgen Macarena
Seville, , Spain
Hospital Clinico Universitario de Valencia
Valencia, , Spain
Hospital Universitari i Politècnic La Fe
Valencia, , Spain
Ankara Bilkent City Hospital Universiteler Mahallesi
Ankara, , Turkey (Türkiye)
Dr. Abdurrahman Yurtaslan Ankara Oncology Training
Ankara, , Turkey (Türkiye)
Gazi Universitesi Tip Fakultesi (Gazi University Faculty of Medicine) - Gazi Hastanesi (Gazi Hospital)
Ankara, , Turkey (Türkiye)
Liv Hospital Ankara - Medical Oncology Clinic
Ankara, , Turkey (Türkiye)
Trakya Universitesi Saglik Arastirma ve Uygulama Merkezi Hastane
Edirne, , Turkey (Türkiye)
Bezmialem University Hospital
Istanbul, , Turkey (Türkiye)
Prof. Dr. Süleyman Yalçın Şehir Hastanesi - Tibbi Onkoloji Klinigi
Kadıköy, , Turkey (Türkiye)
Necmettin Erbakan University
Konya, , Turkey (Türkiye)
Countries
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References
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Wang M, Fan Y, Sun M, Wang Y, Zhao Y, Jin B, Hu Y, Han Z, Song X, Liu A, Tang K, Ding C, Liang L, Wu L, Gao J, Wang J, Cheng Y, Zhou J, He Y, Dong X, Yao Y, Yu Y, Wang H, Sun S, Huang J, Fang J, Li W, Wang L, Ren X, Zhou C, Hu Y, Zhao D, Yang R, Xu F, Huang Y, Pan Y, Cui J, Xu Y, Yang Z, Shi Y. Sunvozertinib for patients in China with platinum-pretreated locally advanced or metastatic non-small-cell lung cancer and EGFR exon 20 insertion mutation (WU-KONG6): single-arm, open-label, multicentre, phase 2 trial. Lancet Respir Med. 2024 Mar;12(3):217-224. doi: 10.1016/S2213-2600(23)00379-X. Epub 2023 Dec 12.
Other Identifiers
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DZ2022E0005
Identifier Type: -
Identifier Source: org_study_id
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